AVERT implementation for your trial is like any other clinical test in your protocol.  Very little training for the site and almost no training for the patient is required. Set-up Overview:

  1. The site registers the patient ID in the system
  2. The patient contacts the system, enters their patient ID and creates a personal PIN
  3. The patient responds to each question and the system branches and probes as  appropriate, conducting a “perfect” interview, and capturing all of the responses
  4. ERT immediately delivers a findings report for site review
  5. The site follows up with the patient per the protocol
  6. ERT calls the site directly if there is a positive finding for suicidal ideation or behavior
  7. Implementation / Operations Overview Presentation
  8. The eC-SSRS Findings Report
imac background
 

AVERT implementation for your trial is like any other clinical test in your protocol.  Very little training for the site and almost no training for the patient is required.

Set-up Overview:

  1. The site registers the patient ID in the system
  2. The patient contacts the system, enters their patient ID and creates a personal PIN
  3. The patient responds to each question and the system branches and probes as  appropriate, conducting a “perfect” interview, and capturing all of the responses
  4. ERT immediately delivers a findings report for site review
  5. The site follows up with the patient per the protocol
  6. ERT calls the site directly if there is a positive finding for suicidal ideation or behavior
  7. Implementation / Operations Overview Presentation
  8. The eC-SSRS Findings Report

Policy and Protocols

Adding the Columbia scale to your clinical development programs is straightforward.  ERT’s scientific consultants as well as Drs. Greist, Jefferson, and Posner are available to work with your medical staff and clinical teams to help create a standard policy for Prospective Assessment of Suicidal Ideation and Behaviors for your compound, therapeutic area, or company. This policy can outline the where – in which compounds, when – to be scheduled in the trial, and how – to implement this assessment. The C-SSRS can be added to your protocols as part of your schedule of assessments.  It is generally performed at every visit per standard FDA Guidance.  In addition, an appendix outlining how to perform the eC-SSRS is added to your protocol.   A sample is included here.

Policy and Protocols – Adding the Columbia scale to your clinical development programs is straightforward.  ERT’s scientific consultants as well as Drs. Greist, Jefferson, and Posner are available to work with your medical staff and clinical teams to help create a standard policy for Prospective Assessment of Suicidal Ideation and Behaviors for your compound, therapeutic area, or company. This policy can outline the where – in which compounds, when – to be scheduled in the trial, and how – to implement this assessment. The C-SSRS can be added to your protocols as part of your schedule of assessments.  It is generally performed at every visit per standard FDA Guidance.  In addition, an appendix outlining how to perform the eC-SSRS is added to your protocol.   A sample is included here.

Versions – There are two versions of the eC-SSRS

Lifetime –This is the version used for all patients for their first interview.  The time frame is in their lifetime and all questions are poised as “have you ever”.   The Recency portion of the scale confirms if these thoughts or behaviors occurred in the past x months.  This section is programmable for ideation and behavior time periods separately or can be shut off completely.  This is generally used to assess protocol screening / exclusion criteria.

Since Last Interview – This version is used for all subsequent calls. The system recalls the date of the last interview – even if it was a clinician interview – and poses the questions as “since your last interview, month xx, xx days ago, have you”.  This enables us to collect a continuum of experience for each patient.

Using the C-SSRS and eC-SSRS – The FDA has said that it will accept “mixing” the C-SSRS and eC-SSRS applications in the same trial, if it would facilitate patient monitoring. The data management aspects of this approach are reviewed below. Some examples of this might be:

  • Implementing the eC-SSRS mid trial
  • Using the clinician interview (C-SSRS) to follow up on a positive eC-SSRS
  • Reporting non-interview information, i.e. from a spouse or in case of hospitalization or death
  • Using the C-SSRS in some countries and eC-SSRS in others

C-SSRS and eC-SSRS Versions – As outlined on the Columbia website, there are numerous C-SSRS versions tailored to fit unique circumstances. The table below outlines the eC-SSRS application for each C-SSRS version.

cssrs

Visit the eC-SSRS and C-SSRS website

Versions – There are two versions of the eC-SSRS

Lifetime

This is the version used for all patients for their first interview.  The time frame is in their lifetime and all questions are poised as “have you ever”.   The Recency portion of the scale confirms if these thoughts or behaviors occurred in the past x months.  This section is programmable for ideation and behavior time periods separately or can be shut off completely.  This is generally used to assess protocol screening / exclusion criteria.

Since Last Interview

This version is used for all subsequent calls. The system recalls the date of the last interview – even if it was a clinician interview – and poses the questions as “since your last interview, month xx, xx days ago, have you”.  This enables us to collect a continuum of experience for each patient.

Using the C-SSRS and eC-SSRS – The FDA has said that it will accept “mixing” the C-SSRS and eC-SSRS applications in the same trial, if it would facilitate patient monitoring. The data management aspects of this approach are reviewed below. Some examples of this might be:

  • Implementing the eC-SSRS mid trial
  • Using the clinician interview (C-SSRS) to follow up on a positive eC-SSRS
  • Reporting non-interview information, i.e. from a spouse or in case of hospitalization or death
  • Using the C-SSRS in some countries and eC-SSRS in others

C-SSRS and eC-SSRS Versions – As outlined on the Columbia website, there are numerous C-SSRS versions tailored to fit unique circumstances. The table below outlines the eC-SSRS application for each C-SSRS version.

cssrs

Visit the eC-SSRS and C-SSRS website

galaxy_s5 background
 

Project Management

ERT’s standard Project Assurance process, used in over 1,100 active studies around the world, will be used to manage the EXPERT application of the eC-SSRS for your trial.  A project manager will be involved from project kickoff through data close out.  This process is outlined in this presentation. The Study Requirement Specification (PRS) will outline the study specifications including reporting and alerting.  Much more detail is available through your ERT contact and our Project Assurance team. Training –  Everyone using the Columbia scale must be licensed and have been oriented to its content and use.  This training is provided via DVD and live Q/A during the investigator meeting and scheduled by the Center for Suicide Risk Assessment – Dr. Kelly Posner. When the eC-SSRS is used, the license and training are included in the program fees. In addition, training for ERT’s EXPERT ePRO system – registering the patient, receiving reports and using the study portal is provided by ERT’s Academy staff at the investigator meeting. Both the Columbia and ePRO training can be completed in an hour.

Data Management –  View the the recommended Data Analysis Guide for the C-SSRS developed by an industry workgroup and reviewed by the FDA.

C-CASA / C-SSRS / eC-SSRS Data –  The C-CASA is in retrospective reviews and results in the most basic findings classifications. The C-SSRS prospectively collects these assessments, enabling the next, more detailed level of findings. Similarly, using the eC-SSRS we capture even more data including all the responses to the probing questions.  Therefore the eC-SSRS database is the most comprehensive, and inclusive of the data items from the C-SSRS and C-CASA.  In this way, the database ERT delivers from the eC-SSRS self-rated interviews can easily be coordinated with any other C-SSRS data collected, or even legacy C-CASA analyses. As part of this assessment and data collection effort we will need the ability to gather assessment data from a variety of sources including previous trials and even the current trial due to:

  • Implementing the eC-SSRS mid trial
  • Using the clinician interview (C-SSRS) to follow up an eC-SSRS
  • Reporting non-interview information, i.e. from a spouse or in case of hospitalization or death
  • Using the C-SSRS in some countries and eC-SSRS in others

While almost all data will be collected through the eC-SSRS system, you still need to have your legacy C-SSRS data collection available for these ad-hoc items.

Data Specification – ERT’s standard eC-SSRS data specifications. Our project management team will work with you and our data team to modify this specifications document to meet your needs, including coordination with your legacy C-SSRS data collection.

For additional information see our brief FAQ document.